Regulatory Lead

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Japan- home-based, with expected travel to the BSI Yokohama office and international travel on a needs basis

BSI Regulatory Services are looking for a Regulatory Lead who leads BSI in maintaining Registered Certification Body Status and PMDA Scheme in Japan - including Regulatory Intelligence, NC/OFI ownership, designated main liaison with the MHLW/PMDA, internal/external audit interface and reporting of any compliance concerns.

• Provide regulatory input and expertise to the Operations Teams, e.g. Scheme Managers, QMS, Commercial
• Own, update, and provide training on Japan specific procedures/forms in the BMS
• Complete reviews of external documents that impact on BSI’s QMS to include Regulatory Intelligence updates
• Support/Deliver certification decisions and regulatory/confirmation letter approvals
• Lead the external audit process and support the closure of all non-conformities raised during audits to ensure BSI continued operation as an Registered Certification Body
• Act as the primary interface for the internal audit and provide support as necessary
• Lead on all change notifications to the MHLW/PMDA, as necessary
• Lead and provide additional support (where necessary) the development and implementation of the necessary processes and procedures to ensure continuous compliance with registration/ designation/ accreditation requirements
• Provide advice to the business in the process of developing new and revised services and products taking cognizance of the risks to the business
• Act as the primary interface between the MHLW/PMDA and BSI
• Lead and participate in process improvement projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement
• Represent BSI in regulatory forums internally and externally – assume primary responsibility in attending the ARCB on behalf of BSI Japan

• First or second degree in Engineering, Science, or related discipline
• Native level of Japanese, business fluency in English
• Thorough understanding of technical documentation required by the manufacture of medical devices including the applicable regulations and standards
• Thorough knowledge of Medical Device QMS standards and regulation
• A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements
• Good relationship building skills, with internal and external stakeholders
• Broad technical understanding of client industry products

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of up to 14-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, commuting allowance, paid maternity leave, paid paternity leave, paid parental leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.

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BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.